FDA Announces New Prescription Drug Information Format

The U.S. Food and Drug Administration (FDA) today unveiled a
major revision to the format of prescription drug information,
commonly called the package insert, to give healthcare
professionals clear and concise prescribing information. In an
effort to manage the risks of medication use and reduce medical
errors, the newly designed package insert will provide the most
up-to-date information in an easy-to-read format that draws
physician and patient attention to the most important pieces of
drug information before a product is prescribed. The new format
will also make prescription information more accessible for use
with electronic prescribing tools and other electronic information
resources.

"Providing healthcare professionals and patients with clear and
concise information about prescriptions will help ensure safe and
optimal use of drugs, which translates into better health outcomes
for patients and more efficient delivery of healthcare," said HHS
Secretary Mike Leavitt. "By improving the package insert to make it
more useful for healthcare providers in their day-to-day clinical
practice, we are making it easier for them to explain the benefits
and risks of medications for their patients."

Each year, approximately 300,000 preventable adverse events
occur in hospitals in this country, many as a result of confusing
medical information. Research shows that prioritizing the warning
information has a greater impact on reducing such events.
Therefore, the new prescription label format provides the most
important information about a prescription product in a format that
is better understood, more easily accessible and more memorable for
physicians. By making these changes, FDA is seeking to reduce the
complexity of information on prescription drug labels, making them
more useful for physicians and their patients.

"Americans are overwhelmed with the complexity of health
information. We have hit a point of information overload and the
public health message is being diluted," said Richard H. Carmona,
M.D., M.P.H., FACS, U.S. Surgeon General. "This is of great concern
when it comes to making sure a patient knows how to use
prescription drugs safely and effectively. This problem is
compounded by prescription medication information that reads more
like legal disclaimers than useful or actionable health
information."

Revised for the first time in more than 25 years, the new format
requires that the prescription information for new and recently
approved products meet specific graphical requirements and includes
the reorganization of critical information so physicians can find
the information they need quickly. Some of the most significant
changes include:

A new section called Highlights to provide immediate
access to the most important prescribing information about benefits
and risks.

A Table of Contents for easy reference to detailed
safety and efficacy information.

The date of initial product approval, making it easier to
determine how long a product has been on the market.

A toll-free number and Internet reporting information for
suspected adverse events to encourage more widespread reporting of
suspected side effects.

"The new label design makes it easier for doctors to get access
to important information about drug safety and benefits, and this
in turn will help them have more meaningful discussions with their
patients," said Andrew von Eschenbach, M.D., FDA Acting
Commissioner of Food and Drugs. "This redesigned label is a big
step in our commitment to giving health professionals the tools and
information they need to optimize their clinical practice and
choose among a growing number of effective treatments to make more
personalized prescribing decisions for their patients."

The most notable change is the addition of a summary outlining
the most important information about a product, prominently
displayed at the top of the page. Designed to help healthcare
professionals find the information they need quickly,
Highlights will typically be half a page in length and will
provide a concise summary of information about specific areas
including: Boxed Warning, Indications and Usage, and
Dosage and Administration; and will refer the healthcare
professional to the appropriate section of the Full Prescribing
Information. In addition, drug makers will be required to
include a list of all substantive recent changes made within the
year, to ensure healthcare professionals have immediate access to
the most up-to-date information about the product before
prescribing it.

Over the past ten years, the prescribing information for newly
approved products has become increasingly more complex, and
specific information is often difficult to locate. Physicians will
now be able to find critical information more quickly, through a
new Table of Contents that refers readers to detailed
information located in the label. The Full Prescribing
Information is reorganized to give greater prominence to the
most important and most commonly referenced information. As a
result of feedback from two national physician surveys, the
Indications and Usage and the Dosage and
Administration sections are moved to the beginning of the
Full Prescribing Information.

The addition of a new Patient Counseling Information
section places greater emphasis on the importance of communication
between professionals and patients. This new section is designed to
help doctors advise their patients about important uses and
limitations of medications. It will also serve as a guide for
discussions about the potential risks involved in taking a specific
treatment and steps for managing those risks. If FDA has approved
patient information for a prescription drug, it will be printed at
the end of the label immediately following the Patient
Counseling Information section or will accompany the label so
it can be easily shared.

"In the last month, we have announced important steps toward
creating an electronic environment for drug safety and
effectiveness information that can provide patients and healthcare
professionals with critical information at the point of care," said
von Eschenbach. "This revised prescription information format, in
combination with new requirements for electronic labels announced
earlier this month and requirements for barcodes on drugs will
dramatically improve the way healthcare professionals and consumers
obtain information about prescription drugs."

The new prescription information format will be integrated into
FDA's other e-Health initiatives and standards-setting efforts
through a variety of ongoing initiatives at the agency. As
prescription information is updated in this new format it will be
used to provide medication information for DailyMed -- a new
interagency online health information clearinghouse that will
provide the most up-to-date medication information free to
consumers, healthcare professionals and healthcare information
providers. The DailyMed is now making up-to-date information
about FDA-regulated products widely available on the Internet free
of charge. This information can be accessed through the National
Library of Medicine at http://dailymed.nlm.nih.gov.
In the future, this new information will also be provided through a
website called facts@fda, a comprehensive Internet resource
designed to give one-stop access for information about all
FDA-regulated products.

In December 2000, before issuing the proposed rule the agency
evaluated extensive information it received on the usefulness of
the present prescription drug labeling for healthcare professionals
to determine how content and format could be improved. The agency
used feedback from focus groups, national physician surveys, a
public meeting and written comments to design the new prescription
information format. FDA determined the most common practices for
using prescription drug labeling, as well as information considered
to be most important, and then developed the new format based on
this information. The new drug labeling requirements will be phased
in gradually and initially will apply to newly and recently
approved prescription drugs and drugs that receive approval for new
uses. The agency is encouraging drug makers to consider complying
with the new labeling requirements earlier on a voluntary basis.
All drugs approved within the past five years are included, and
they will gradually be converted to the new prescribing information
format.

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